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The Midlands and North of England Stillbirth Study (MiNESS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Manchester
Sponsor:
Information provided by (Responsible Party):
Dr Alexander Heazell, University of Manchester
ClinicalTrials.gov Identifier:
NCT02025530
First received: December 20, 2013
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

The United Kingdom has one of the highest rates of stillbirth in Europe, with more than 4,000 stillbirths every year; which equates to more than 11 deaths every day. Furthermore, this rate has changed very little over the last 20 years. This loss of life and the adverse psychological consequences urgently needs addressing.

A recent New Zealand study investigating modifiable factors associated with stillbirth (the Auckland Stillbirth Study) found that mothers who did not go to sleep on their left side had a twofold risk of late stillbirth (≥28 weeks gestation) compared to mothers who did go to sleep on their left side. These novel findings need urgent confirmation.

This proposed study aims to confirm or refute these findings and to ascertain whether a preventative programme should be introduced. This proposed study aims to confirm or refute the findings of the Auckland Stillbirth Study.

Participants will be recruited from maternity units in the Midlands and North of England (led by centres in Liverpool, Manchester, West Yorkshire and Birmingham). 291 women with a singleton late stillbirth without congenital abnormality will be interviewed by research midwives shortly after the birth. A control group of 580 women with ongoing pregnancies will be interviewed at a gestation group matched to that at which stillbirths occurred. These data will determine whether an intervention study should be considered. If there is a causal relationship between maternal sleep position and late stillbirth we estimate that upto 37% of late stillbirths might be prevented.


Condition Intervention
Stillbirth.
Other: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Midlands and North of England Stillbirth Study - A Case-Control Study of Modifiable Factors in Late Stillbirth

Resource links provided by NLM:


Further study details as provided by University of Manchester:

Primary Outcome Measures:
  • Identification of modifiable risk factors associated with stillbirth [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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Estimated Enrollment: 871
Study Start Date: April 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cases
A structured questionnaire will be administered to women who have experienced a late ≥ 28 weeks gestation stillbirth, who have a singleton pregnancy with no congenital abnormality.
Other: Questionnaire
An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls
Controls
A structured questionnaire will be administered to controls. These are women matched to the case group by gestation and unit of birth, who have a normal ongoing singleton pregnancy with no congenital abnormality.
Other: Questionnaire
An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls

Detailed Description:

The death of an unborn child is a prevalent and tragic public health problem which currently affects millions of families worldwide. Late stillbirth (at or beyond 28 weeks of gestation) is one of the few potentially avoidable maternal and child health problems where the rate of decline in high income countries has slowed in recent decades [1]. The United Kingdom currently has one of the highest rates of stillbirth in Europe, ranking 33rd out of 35 high income countries.

The variations in stillbirth rates between high income countries suggest that it should be possible to make further reductions in late stillbirths. The estimated annual reduction in rates of late stillbirth over recent decades is about 1.1% [1], compared to 2.1% for neonatal death rates, with a resultant increase in the proportion of perinatal deaths (stillbirths plus neonatal deaths) attributable to stillbirth [2]. The Lancet Stillbirth Series [1, 3, 4] has highlighted the silent but prevalent public health problem of stillbirth and together with Sands and the Royal College Of Obstetricians and Gynaecologists has called for research to address these unacceptably high rates.

Current established risk factors for late stillbirth in high income countries include: advanced maternal age (>35 years) [5], high pre-pregnancy body mass index (BMI) [6], smoking [7], reduced antenatal care attendance [8], low socioeconomic status [8] and small for gestational age (SGA) infants [9]. A meta-analysis of population based studies addressing risk factors for stillbirth found that the three most important modifiable risk factors were overweight and obesity (population attributable risk 818%) advanced maternal age (population attributable risk 68%), and smoking (population attributable risk 47%) [3]. Of these only, cigarette smoking may be realistically addressed after pregnancy has started. There has been limited research investigating the role of novel, modifiable factors which have the potential to advance knowledge and address the important gaps in the field of stillbirth research.

This study aims to explore modifiable risk factors for late stillbirth in the UK and to substantiate the recent identification of a new modifiable risk factor for unexpected late pregnancy stillbirths. In the Auckland Stillbirth Study [10] our New Zealand collaborators discovered an approximately two-fold increase in late stillbirth with non-left sided maternal sleep position on the night before the baby died. In addition, women who did not get up at night and those who slept during the day were also at increased risk of stillbirth. The strength of this primary finding was unanticipated and now maternal sleep position requires urgent, rigorous evaluation in another population. MiNESS aims to address these factors.

This multi-centered case control study will recruit 291 women who have experienced a late (≥28 weeks gestation) matched with 580 women who have a continuing pregnancy at the same gestation (controls). The women will be interviewed by an experienced research midwife and an in depth questionnaire will be completed.

Analysis will be carried out using the standard Mantel-Haenszel odds ratio analysis used in case-control studies. Unconditional logistic regression will be used to adjust for potential confounders and to determine the presence of interactions.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The sample will be recruited from maternity units in the Midlands and the North of England.

Criteria

Inclusion Criteria: CASES

  • Women who experience a stillbirth ≥28 weeks gestation in a participating unit.

Exclusion Criteria:

  • Fetal death prior to 28 weeks gestation.
  • Women who's babies have a significant congenital abnormality.
  • Women with multiple pregnancy.
  • Maternal age below 16 years.
  • Women unable to give informed consent.

Inclusion Criteria: CONTROLS

  • Women with a normal pregnancy matched to gestation and unit of birth to the cases.

Exclusion Criteria:

  • Pregnancy under 28 weeks gestation.
  • Women who's babies have a significant congenital abnormality.
  • Women with multiple pregnancy.
  • Maternal age below 16 years.
  • Women unable to give informed consent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025530

Contacts
Contact: Alexander Heazell 0161 701 6968 alexander.heazell@manchester.ac.uk

Locations
United Kingdom
Liverpool Women's NHS Foundation Trust Recruiting
Liverpool, Merseyside, United Kingdom, L8 7SS
Contact: Devender Roberts    0151 702 4317    devender.roberts@iwh.nhs.uk   
Principal Investigator: Devender Roberts         
Birmingham Women's Hospital NHS Foundation Trust Recruiting
Birmingham, West Midlands, United Kingdom, B15 2TG
Contact: Bill Martin    0121 607 4708    bill.martin@bwhct.nhs.uk   
Principal Investigator: Bill Martin         
Mid Yorkshire NHS Trust Recruiting
Dewsbury, Yorkshire, United Kingdom, WF13 4HS
Contact: Tomasina Stacey    07580 345393    t.stacey@bradford.ac.uk   
Principal Investigator: Tomasina Stacey         
Central Manchester University Hospitals NHS Foundation Trust Recruiting
Manchester, United Kingdom, M13 9WL
Contact: Alexander Heazell    0161 701 6968    alexander.heazell@manchester.ac.uk   
Contact: Jayne Platts    0161 701 6961    jayne.platts@cmft.nhs.uk   
Principal Investigator: Alexander Heazell         
Sponsors and Collaborators
University of Manchester
Investigators
Principal Investigator: Tomasina Stacey Mid Yorkshire NHS Trust
Principal Investigator: Edwin Mitchell University of Auckland, New Zealand
Principal Investigator: Lesley McCowan University of Auckland, New Zealand
Principal Investigator: Bill Martin Birmingham Women's Hospital NHS Foundation Trust
Principal Investigator: Devender Roberts Liverpool Women's NHS Foundation Trust
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Alexander Heazell, Senior Clinical Lecturer in Obstetrics, University of Manchester
ClinicalTrials.gov Identifier: NCT02025530     History of Changes
Other Study ID Numbers: GN2156
Study First Received: December 20, 2013
Last Updated: May 1, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Manchester:
Stillbirth
Modifiable risk factors

ClinicalTrials.gov processed this record on July 24, 2014